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Jazz Pharmaceuticals Announces U.S. FDA Accelerated Approval of Zepzelca™ (lurbinectedin) for the Treatment of Metastatic Small Cell Lung Cancer

(Jazz) June 15, 2020 - Jazz Pharmaceuticals plc today announced along with its partner PharmaMar that the U.S. Food and Drug Administration (FDA) approved Zepzelcaâ„¢ (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Zepzelca was approved under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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H. Jack West, MD (Posted: June 16, 2020)

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We await phase 3 data, but many will welcome a new option with an approximately 35% response rate in phase 2 work to this point. Relapsed small cell lung cancer is a clinical setting in which the FDA-approved standard of care, topotecan, is not widely embraced, due to its significant hematologic toxicity and requirement for 5 days of IV therapy each cycle. The cost of lurbinectedin should lead oncologists to expect to be impressed by phase III data, and many may wait for more data before prescribing it. There is also rather low awareness of lurbinectedin in the broad oncology community and even limited awareness among many thoracic oncologists.

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